GlaxoSmithKline has received Food and Drug Administration approval to start shipping 2013-14 Fluarix Quadrivalent influenza virus vaccine to U.S. health care providers and Centers for Disease Control and Prevention (CDC) distribution centers.


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GSK cleared to ship four-strain flu vaccine

August 6th, 2013

PHILADELPHIA – GlaxoSmithKline has received Food and Drug Administration approval to start shipping 2013-14 Fluarix Quadrivalent influenza virus vaccine to U.S. health care providers and Centers for Disease Control and Prevention (CDC) distribution centers.

GSK said Monday that 2013-14 marks the first flu season in which vaccinations protecting against more than three strains of flu will be commercially available.

Fluarix Quadrivalent will soon be supplied to U.S. health providers that placed orders for the new vaccine after it was approved late last year, according to GSK. The company said that for this flu season it will supplement the supply of Fluarix Quadrivalent with its trivalent seasonal influenza vaccines.

In the United States, GSK estimates it will provide up to 10 million doses of quadrivalent flu vaccines, and 22 million to 24 million doses of flu vaccines overall.

GSK said it expects the health care community to steadily transition to quadrivalent influenza vaccines in the coming years, and the company is in the process of increasing its capability to provide substantially more quadrivalent flu vaccine doses for upcoming influenza seasons.

Fluarix Quadrivalent was the first intramuscular quadrivalent influenza vaccine approved by the FDA, in December 2012, for the immunization of children (three years and older) and adults to help prevent seasonal influenza virus subtypes A and B contained in the vaccine. Before vaccine manufacturers can begin shipping flu vaccines each season, the FDA first must certify that the supplies provided to health care providers meet quality and safety standards.

Scientists classify the influenza strains that cause seasonal flu as A or B strains. Most current flu vaccines provide trivalent (three-strain) influenza protection. Trivalent flu vaccines protect against the two A virus strains most common in humans and the B strain expected to be predominant in a given year.

"Trivalent influenza vaccines offer important protection against influenza. But since the late 1980s, scientists noted that two B virus lineage strains circulate to varying degrees each year, and it's difficult to predict which one will cause the most illness in a particular influenza season," explained Dr. Leonard Friedland, vice president of scientific affairs and public policy for GSK Vaccines North America. "Fluarix Quadrivalent addresses this by protecting against both B strains."

Late last month, AstraZeneca's MedImmune announced that it began shipping FluMist Quadrivalent, a nasal spray flu vaccine that protects against four influenza strains, in the United States for the 2013-14 flu season. And in June, Sanofi Pasteur said it had received FDA approval to release its Fluzone Quadrivalent four-strain flu vaccine in the United States for the coming influenza season.

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